MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. CRESCENT SPINAL SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Urinary Retention (2119)

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

A multi-center retrospective observational study was conducted to obtain post-market clinical data for medtronic spine implantable devices.This data was queried and grouped based on the specific medtronic system used in the surgical procedure and analyzed to establish real-world evidence (rwe) for the performance and safety of the device in question when used as part of standard clinical practice.This data collection is one part of ongoing post-market clinical surveillance activities that are intended to confirm and monitor the safety and performance of the device.This report summarizes the clinical data obtained by medtronic as part of this retrospective observational study.Data obtained as part of this study was provided to in a de-identified format and thereby provides no patient or product specific identifiers.Total patients: 19 (male: 07, female: 12), ages: 47 years to 79 years, bmi: 20 kg/square-metre to 42 kg/square-metre procedure involved: transforaminal lumbar interbody fusion (tlif), posterior spinal fusion (psf) levels operated: lumbar, lumbar-sacral, thoracic-lumbar-sacral as per this clinical evaluation report, it was reported that a total of 19 patients having a clinical diagnosis and documented surgical implantation of the alleged spinal system were followed-up.Based on the radiographic diagnoses, patients were stratified into one of three evidence groups for analysis: degenerative disease (14 patients), deformity (4 patients), failed fusion (1 patient).Post-op, adverse events were reported only in degenerative disease group.The following were the adverse events that were noted: events related to spine fusion surgery: adjacent segment changes (2) and drop foot (1).Revision surgery: 2 patients underwent revision surgery due to adjacent segment changes/construct extension.The revision surgeries were not anticipated to be related to the spinal system under study.Events related to general surgery: surgical wound complications (4).D) other adverse events that may be related to general surgery and/or spine surgery: urinary retention (1).None of the reported revision surgeries can be directly attributed to the spinal system under study.Other reported adverse events were known complications associated with spine fusion surgery or general surgery.Overall, the results from this retrospective observational study indicate that this spinal system is safe and effective when used as intended.No new or emerging risks were identified.

• Brand Name: CRESCENT SPINAL SYSTEM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 10190870
• MDR Text Key: 201056794
• Report Number: 1030489-2020-00708
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention